NCT06740253

Safety and Acceptability Study of a Placebo Antibody-Based Nonhormonal Contraceptive Intravaginal Ring

Safety and Acceptability Study of MM008-IVR, an Antibody-Based Nonhormonal Contraceptive Intravaginal Ring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.

Detailed description

There is a gap in commercially available reliable, effective contraception methods that do not contain hormones. Mucommune is developing a novel non-hormonal contraceptive in the form of a capsule-intravaginal ring (IVR) that releases highly potent contraceptive antibodies (MM008) that rapidly bind and trap sperm. These antibodies have been developed over the past 5 years and the target on sperm cells was initially obtained from a patient with infertility due to anti-sperm antibodies.

Conditions

• Healthy Female Subjects

Interventions

Type	Name	Description
DEVICE	Placebo intravaginal ring (IVR)	Antibody-Based Nonhormonal Placebo Contraceptive Intravaginal Ring

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2024-12-18
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States